ELIGLUSTAT TARTRATE - Generic Drug Details

What are the generic sources for eliglustat tartrate and what is the scope of patent protection?

Eliglustat tartrate is the generic ingredient in two branded drugs marketed by Genzyme Corp, Aizant, Dr Reddys, Teva Pharms Usa Inc, and Upsher Smith Labs, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eliglustat tartrate has one hundred and sixty-one patent family members in forty-four countries.

There are six drug master file entries for eliglustat tartrate. One supplier is listed for this compound.

Summary for ELIGLUSTAT TARTRATE

International Patents:	161
US Patents:	4
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	6
Patent Applications:	176
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIGLUSTAT TARTRATE
DailyMed Link:	ELIGLUSTAT TARTRATE at DailyMed

Recent Clinical Trials for ELIGLUSTAT TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sanofi	Phase 1
Genzyme, a Sanofi Company	Phase 1
Genzyme, a Sanofi Company	Phase 3

See all ELIGLUSTAT TARTRATE clinical trials

Pharmacology for ELIGLUSTAT TARTRATE

Drug Class	Glucosylceramide Synthase Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Glucosylceramide Synthase Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for ELIGLUSTAT TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CERDELGA	Capsules	eliglustat tartrate	84 mg	205494	6	2018-08-20

US Patents and Regulatory Information for ELIGLUSTAT TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212449-001	Aug 17, 2022		DISCN	No	No
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes
Aizant	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212463-001	Sep 8, 2021	AB	RX	No	No
Teva Pharms Usa Inc	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212474-001	Dec 27, 2021		DISCN	No	No
Upsher Smith Labs	ELIGLUSTAT TARTRATE	eliglustat tartrate	CAPSULE;ORAL	212420-001	May 2, 2023	AB	RX	No	No
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes			Y	Y
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes				Y

Expired US Patents for ELIGLUSTAT TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014

International Patents for ELIGLUSTAT TARTRATE

Country	Patent Number	Title	Estimated Expiration
Israel	275091	שיטות לטיפול במחלת גושה (Methods for treating gaucher disease)
Brazil	122015016314	método para preparar um composto acíclico, método para preparar um composto amina, método de preparar um composto como esfingosina e método para preparar um composto como ceramida
Taiwan	201130822	Inhibitors of glucosylceramide synthase
Denmark	2266968
Portugal	2067775
Serbia	53503	AMORFNA I KRISTALNA FORMA GENZ 112638 HEMITARTARATA KAO INHIBITOR GLIKOZILKERAMID SINTAZE (AN AMORPHOUS AND A CRYSTALLINE FORM OF GENZ 112638 HEMITARTRATE AS INHIBITOR OF GLUCOSYLCERAMIDE SYNTHASE)
European Patent Office	2796457	Genz 112638 pour le traitement de la maladie de Gaucher ou de Fabry en polythérapie (Genz 112638 for treating Gaucher or Fabry disease in combination therapy)

Supplementary Protection Certificates for ELIGLUSTAT TARTRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1409467	244 4-2015	Slovakia		PRODUCT NAME: ELIGLUSTAT (VO FORME TARTRATU); REGISTRATION NO/DATE: EU/1/14/974 20150121
1409467	C300738	Netherlands		PRODUCT NAME: ELIGLUSTAT, OF FYSIOLOGISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	37/2015	Austria		PRODUCT NAME: ELIGLUSTAT, OPTIONAL IN DER FORM EINES PHYSIOLOGISCH AKZEPTABLEN SALZES; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	2015/027	Ireland		PRODUCT NAME: ELIGLUSTAT, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	122015000051	Germany		PRODUCT NAME: ELIGLUSTAT; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	15C0036	France		PRODUCT NAME: ELIGLUSTAT,EVENTUELLEMENT SOUS FORME D'UN SEL PHYSIOLOGIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/14/974 20150119
1409467	132016000023075	Italy		PRODUCT NAME: ELIGLUSTAT, OPZIONALMENTE NELLA FORMA DI UN SALE FARMACOLOGICAMENTE ACCETTABILE(CERDELGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/974, 20150119